NCT04111952

The Effect of Additional Laser Treatments.

The Efficacy and Safety of an Additional Vaginal Laser Treatment in Women Previously Treated With Laser for Gynecological Indications.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Women previously treated with vaginal CO2 laser will receive an additional treatment 6 months after cessation of previous laser treatment or a sham laser treatment. The efficacy and safety of the additional treatment will be assessed.

Detailed description

The following study is intended to evaluate the efficacy and safety of an additional laser treatment for women previously treated for gynecological indications with laser treatments. Women will be randomized to one of 2 groups: 1. Study group-additional single laser treatment. 2. Control group-single sham laser treatment. All women will fill out validated questionnaires regarding sexual function, urinary stress incontinence and satisfaction after treatment. All women will be followed for an additional 6 months to evaluate the length of effect.

Conditions

• Lax Vaginal Introitus

Interventions

Type	Name	Description
DEVICE	CO2 laser	A single session of CO2 vaginal laser treatment
DEVICE	Sham laser	A single session of sham laser treatment.

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-11-01
• Completion: 2023-01-28
• First posted: 2019-10-02
• Last updated: 2022-04-20

Locations

1 site across 1 country: Israel